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<p>The Department fully understands that maintaining access to epilepsy medications
is vitally important to many people in this country.</p><p>The production of medicines
is complex and must meet rigorous quality and safety standards. Disruption to the
medicines supply chain is rare, but can occur due to manufacturing issues, supply
of raw materials or batch failures.</p><p>The Department has well established processes
to monitor the medicines supply chain, and to manage and mitigate the small number
of supply problems that may arise at any one time. In addition, from January this
year, it became a legal requirement for pharmaceutical companies to report this information
to us in a timely manner. The new requirements aim to address the ongoing concerns
about medicine supply issues and to ensure that the Department has relevant information
at the earliest point possible to help manage supply shortages and mitigate any potential
impacts on patients.</p><p>The Department responded to concerns over medicines used
in epilepsy by seeking specialist advice to develop a clinical management plan. The
clinical management plan aims to ensure treatment for affected patients can be managed
appropriately in the unlikely event of any disruption to supply. We communicated information
about the supply issue and clinical management plan to the National Health Service
and affected patients via patient groups.</p><p>We continue to work closely with industry
and partners in the health system to help prevent shortages and to ensure that the
risks to patients are minimised when supply issues do arise.</p>
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